[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Rules and Regulations]
[Pages 22620-22625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9849]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0102; FRL-8871-4]


Triflusulfuron-Methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
triflusulfuron-methyl in or on beet, garden, roots and beet, garden, 
tops. Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 22, 2011. Objections and 
requests for hearings must be received on or before June 21, 2011, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0102. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: <a href="/cdn-cgi/l/email-protection#137d7c7f7f767d3d7f72666172537663723d747c65"><span class="__cf_email__" data-cfemail="09676665656c672765687c7b68496c7968276e667f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-0102 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
June 21, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0102, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The

[[Page 22621]]

Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E7669) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.492 be amended by 
establishing tolerances for residues of the herbicide triflusulfuron-
methyl, 2-[[[[[4-(dimethylamino)-6-(2,2,2-trifluoroethoxy)-1,3,5-
triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-methylbenzoate, in or on 
beet, garden, roots at 0.01 parts per million (ppm); and beet, garden, 
tops at 0.02 ppm. That notice referenced a summary of the petition 
prepared on behalf of IR-4 by DuPont Crop Protection, the registrant, 
which is available in the docket, http://www.regulations.gov. Comments 
were received on the notice of filing. EPA's response to these comments 
is discussed in Unit IV.C.
    EPA has revised the tolerance expression for all established 
commodities to be consistent with current Agency policy and has made a 
technical correction to the chemical name. The reasons for these 
changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for triflusulfuron-methyl, 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
triflusulfuron-methyl follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Triflusulfuron-methyl is of low acute toxicity when administered 
orally, dermally, or via inhalation. It is not a dermal sensitizer or 
irritant, and causes only minor transient irritation to the eye. The 
primary target organs identified for triflusulfuron-methyl are the 
liver, testes, and red blood cells. Hematological and histopathological 
changes consistent with mild hemolytic anemia were observed in the rat 
and the dog. Following subchronic and/or chronic dietary exposure, 
increased incidence of testicular interstitial hyperplasia was observed 
in the rat, and testicular atrophy and reduced size were observed in 
the dog. Liver effects including histopathology and increased weight 
were observed in the dog and mouse, but not in the rat.
    No evidence of neurotoxicity was observed except for a 
statistically significant increase in sciatic nerve myelin/axon 
degeneration in female rats at the highest dose tested in the rat 
combined chronic toxicity/carcinogenicity study. However, the incidence 
was high in all dose groups, no increases were seen in the interim 
sacrifice groups or in shorter-term studies, and it is commonly 
observed in older rats.
    In the rat developmental toxicity study, no developmental effects 
were noted, whereas maternal toxicity was observed (decreased body 
weight gain, food consumption and feed efficiency). Abortions occurred 
in the rabbit developmental toxicity study at a dose that also caused 
significant maternal toxicity, including mortality, clinical signs, 
sharply reduced food consumption and decreased weight gain. In the rat 
reproductive toxicity study, decreased parental body weight/weight gain 
and offspring weight during lactation were observed at the mid and high 
doses. No reproductive effects were observed.
    Triflusulfuron-methyl is classified as a possible human carcinogen 
(Group C) under the 1986 Cancer Guidelines, based on an increased 
incidence of benign testicular interstitial cell adenomas in male rats 
in the combined chronic/carcinogenicity toxicity study and evidence of 
clastogenicity in some in vitro genotoxicity studies. A special 
mechanistic study that evaluated hormonal changes in male rats provided 
insufficient information to establish a nonlinear mode of action for 
the formation of these tumors. Additionally, although a statistically 
significant incidence of hepatocellular adenomas was noted in a 
carcinogenicity study in mice, it was within the historical control 
range and not considered as part of the weight-of-evidence for 
determination of cancer classification. Because the observed tumors 
were benign and found in only one species, and only at significantly 
higher dose levels than the dose selected for the point of departure, 
the chronic reference dose (RfD) is considered protective of potential 
carcinogenicity for risk assessment purposes.
    Specific information on the studies received and the nature of the 
adverse effects caused by triflusulfuron-methyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Triflusulfuron-methyl: Revised Human 
Health Risk Assessment for Use in Garden Beet.'' at pages 34-38 in 
docket ID number EPA-HQ-OPP-2010-0102.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a RfD--and a safe margin of exposure

[[Page 22622]]

(MOE). For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
expected in a lifetime. For more information on the general principles 
EPA uses in risk characterization and a complete description of the 
risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for 
triflusulfuron-methyl used for human risk assessment is shown in Table 
1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Triflusulfuron-Methyl for Use in Human Health Risk
                                                   Assessment
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                                      Point of departure and
         Exposure/scenario              uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years      Not required. An appropriate endpoint for this risk assessment was not
 of age and General population,                                       identified.
 including infants and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL= 2.44 mg/kg/day.   Chronic RfD = 0.0244    Chronic oral toxicity/
                                     UFA = 10x                 mg/kg/day.              carcinogenicity in the
                                     UFH = 10x                cPAD = 0.0244 mg/kg/     rat LOAEL = 30.6 mg/kg/
                                     FQPA SF = 1x              day.                    day based on decreased
                                                                                       body weight/weight gain,
                                                                                       hematological changes
                                                                                       (primarily males) and
                                                                                       increased interstitial
                                                                                       cell hyperplasia (males).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..        Classification: Possible Human Carcinogen (Group C, 1986 Cancer
                                       Guidelines), based on increased incidence of testicular interstitial cell
                                        adenomas in rats. The RfD is considered adequately protective of these
                                                                       effects.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to triflusulfuron-methyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing triflusulfuron-methyl 
tolerances in 40 CFR 180.492. EPA assessed dietary exposures from 
triflusulfuron-methyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for triflusulfuron-methyl; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 1994-1996 
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As 
to residue levels in food, EPA utilized tolerance-level residues and 
100 percent crop treated (PCT) for all commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or non-linear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
III.A., EPA has concluded that the use of the chronic RfD is considered 
protective of potential carcinogenicity for risk assessment purposes.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for triflusulfuron-methyl. Tolerance level residues and/or 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for triflusulfuron-methyl in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of triflusulfuron-methyl. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
triflusulfuron-methyl for chronic exposures for non-cancer assessments 
are estimated to be 0.005 parts per billion (ppb) for surface water and 
0.50 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.50 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Triflusulfuron-methyl 
is not registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other

[[Page 22623]]

substances that have a common mechanism of toxicity.'' EPA has not 
found triflusulfuron-methyl to share a common mechanism of toxicity 
with any other substances, and triflusulfuron-methyl does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
triflusulfuron-methyl does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The triflusulfuron-methyl 
toxicity database is adequate to evaluate potential increased 
susceptibility of infants and children, and includes developmental 
toxicity studies in rat and rabbit and a 2-generation toxicity study in 
rat. No developmental effects were seen in the rat developmental 
toxicity study. In the rabbit developmental toxicity study, abortions 
were observed at a dose that also caused significant maternal toxicity, 
including mortality, clinical signs, sharply reduced food consumption 
and decreased weight gain. In the rat 2-generation reproductive 
toxicity study, decreased parental body weight/weight gain and F1 pup 
weight during lactation were observed at the mid and high doses. No 
reproductive effects were observed.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for triflusulfuron-methyl is complete 
except for immunotoxicity testing. Recent changes to 40 CFR part 158 
require immunotoxicity testing (OPPTS Guideline 870.7800) for pesticide 
registration. However, the existing data are sufficient for endpoint 
selection for exposure/risk assessment scenarios, and for evaluation of 
the requirements under the FQPA. There was no evidence of direct 
immunotoxicity in the available studies. Hemolytic anemia, an effect 
associated with exposure to some sulfonylurea compounds, was observed 
for triflusulfuron-methyl. Immune-mediated hemolysis following binding 
to red blood cells has been reported for sulfonylurea drugs such as 
chlorpromamide, although it is not clear that the hemolytic anemia 
observed with triflusulfuron-methyl is related to the immune system. 
However, the hemolytic effects seen in the studies were of low concern 
because the effects were sporadic and marginal (< 10% below controls) 
and a large margin of safety for the effects was provided by the 
selection of the PODs. In the rat, significant hematological 
alterations and regenerative changes were observed at doses >= 100-fold 
above the selected PODs. Effects in the dog were seen at doses >= 15-
fold higher. The Agency does not believe that an immunotoxicity study 
will provide a POD lower than that currently used for risk assessment; 
therefore, an additional UF is not needed to account for the lack of 
this study.
    ii. Although a statistically significant increase in sciatic nerve 
myelin/axon degeneration in high dose female rats was observed in the 
triflusulfuron-methyl rat combined chronic toxicity/carcinogenicity 
study, the incidence was high in all dose groups, no increases were 
seen in the interim sacrifice groups or in shorter-term studies, and 
the lesion is commonly observed in older rats. Therefore, EPA did not 
consider this finding to be evidence of frank neurotoxicity, and there 
is no need for a developmental neurotoxicity study or additional UFs to 
account for neurotoxicity.
    iii. There is no evidence that triflusulfuron-methyl results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to triflusulfuron-methyl in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by triflusulfuron-methyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
triflusulfuron-methyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
triflusulfuron-methyl from food and water will utilize < 1% of the cPAD 
for children 3-5 years old, the population group receiving the greatest 
exposure. There are no residential uses for triflusulfuron-methyl. 
Therefore, the chronic aggregate risk estimates are equivalent to the 
chronic dietary (food + water) risk estimates.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, 
triflusulfuron-methyl is not registered for any use patterns that would 
result in short- or intermediate-term residential exposure. Short- and 
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there 
is no short- or intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess short- and intermediate-term risk), no further assessment of 
short- and intermediate-

[[Page 22624]]

term risk is necessary, and EPA relies on the chronic dietary risk 
assessment for evaluating short- and intermediate-term risk for 
triflusulfuron-methyl.
    4. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.C.iii., the chronic dietary risk assessment is 
protective of any potential cancer effects.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to triflusulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a high-performance liquid 
chromatography with ultraviolet detection (HPLC-UV) method (Method AMR 
1930-91), is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
<a href="/cdn-cgi/l/email-protection#94e6f1e7fdf0e1f1f9f1e0fcfbf0e7d4f1e4f5baf3fbe2"><span class="__cf_email__" data-cfemail="285a4d5b414c5d4d454d5c40474c5b684d5849064f475e">[email protected]</span></a>.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are currently no Codex MRLs established for residues of 
triflusulfuron-methyl in or on commodities associated with this 
petition. However, this action was a work share agreement with Canada's 
Pesticide Management Regulatory Agency (PMRA). While the tolerance for 
beet, garden, roots at 0.01 ppm is harmonized with PMRA, the tolerance 
for beet, garden, tops at 0.02 ppm is not harmonized with PMRA's MRL of 
0.01 ppm for that commodity. Based on the submitted residue data, 
garden beet tops had residue levels equal to 0.01 ppm; given the level 
of uncertainty for quantification around the limit of quantitation 
(0.01 ppm), EPA has determined that a tolerance for beet, garden, tops 
at 0.02 ppm is appropriate.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a 
general objection to the presence of any pesticide residues on crops 
and stated that EPA should set no pesticide tolerance greater than 
zero. The Agency understands the commenter's concerns and recognizes 
that some individuals believe that pesticides should be banned 
completely. However, the existing legal framework provided by section 
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) states that 
tolerances may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. This citizen's comment appears to be 
directed at the underlying statute and not EPA's implementation of it; 
the citizen has made no contention that EPA has acted in violation of 
the statutory framework.

D. Revisions to Petitioned-For Tolerances

    EPA has revised the tolerance expression to clarify: (1) That, as 
provided in FFDCA section 408(a)(3), the tolerance covers metabolites 
and degradates of triflusulfuron-methyl not specifically mentioned; and 
(2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression. Additionally, EPA has revised the chemical name 
from triflusulfuron methyl to triflusulfuron-methyl in order to reflect 
the preferred common name of the chemical.

V. Conclusion

    Therefore, tolerances are established for residues of 
triflusulfuron-methyl, (methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-
trifluoroethoxy)-1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-
methylbenzoate), in or on beet, garden, roots at 0.01 ppm; and beet, 
garden, tops at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the national government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995

[[Page 22625]]

(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 15, 2011.
 Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.492 is amended by revising the section heading and 
paragraph (a) introductory text and alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.492  Triflusulfuron-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of 
triflusulfuron-methyl, including its metabolites and degradates, in or 
on the commodities listed in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
triflusulfuron-methyl (methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-
trifluoroethoxy)-1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-
methylbenzoate) in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Beet, garden, roots........................................         0.01
Beet, garden, tops.........................................         0.02
 
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-9849 Filed 4-21-11; 8:45 am]
BILLING CODE 6560-50-P


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